Naloxone Transdermal Delivery Devices and Methods for Using the Same

Abstract

Naloxone transdermal delivery devices are provided. Aspects of the naloxone transdermal delivery devices include a matrix comprising a naloxone active agent in a pressure sensitive adhesive and a backing layer. Also provided are methods of making and using the naloxone transdermal delivery devices, as well as kits containing the transdermal delivery devices. The devices, kits and methods of using the same find use in a variety of applications.

1 . A transdermal delivery device comprising:
 a matrix comprising a naloxone active agent in a pressure sensitive adhesive; and   a backing layer.   
     
     
         2 . The transdermal delivery device according to  claim 1 , wherein the device is configured to deliver the naloxone active agent to a subject over an extended period of time. 
     
     
         3 . The transdermal delivery device according to  claim 2 , wherein the extended period of time is 1 to 7 days. 
     
     
         4 - 5 . (canceled) 
     
     
         6 . The transdermal delivery device according to  claim 1 , wherein the amount of naloxone active agent in the matrix adhesive layer is 20% w/w or less. 
     
     
         7 . (canceled) 
     
     
         8 . The transdermal delivery device according to  claim 1 , wherein the naloxone active agent is naloxone free base. 
     
     
         9 . The transdermal delivery device according to  claim 1 , wherein the device is configured to deliver an amount of the naloxone active agent to a subject at a rate ranging from 0.1 μg/day to 10,000 μg/day. 
     
     
         10 . (canceled) 
     
     
         11 . The transdermal delivery device according to  claim 1 , wherein the pressure sensitive adhesive comprises an acrylic polymer, acrylate copolymer, acrylate-vinyl acetate copolymer or polyacrylonitrile or mixtures thereof. 
     
     
         12 . The transdermal delivery device according to  claim 11 , wherein the pressure sensitive adhesive comprises a non-functionalized polymer. 
     
     
         13 . The transdermal delivery device according to  claim 12 , wherein the pressure sensitive adhesive comprises a non-functionalized acrylate polymer. 
     
     
         14 . The transdermal delivery device according to  claim 1 , wherein the matrix comprises a cross-linked polymer. 
     
     
         15 . The transdermal delivery device according to  claim 14 , wherein the cross-linked polymer is a crosslinked polyvinylpyrrolidone. 
     
     
         16 . (canceled) 
     
     
         17 . The transdermal delivery device according to  claim 1 , wherein the matrix comprises a skin penetration enhancer. 
     
     
         18 . The transdermal delivery device according to  claim 17 , wherein the skin penetration enhancer comprises a fatty acid. 
     
     
         19 . The transdermal delivery device according to  claim 18 , wherein the fatty acid is a saturated fatty acid. 
     
     
         20 . The transdermal delivery device according to  claim 19 , wherein the saturated fatty acid is a C8 to C16 fatty acid. 
     
     
         21 - 22 . (canceled) 
     
     
         23 . A method administering naloxone to a subject, the method comprising:
 applying to a skin surface of the subject a transdermal delivery device comprising:
 a matrix comprising a naloxone active agent in a pressure sensitive adhesive; and 
 a backing layer; 
   to administer naloxone to the subject.   
     
     
         24 - 59 . (canceled) 
     
     
         60 . The method according to  claim 23 , wherein the method is a method for the treatment or prevention of a side effect from opioid administration in a subject. 
     
     
         61 . (canceled) 
     
     
         62 . The method according to  claim 23 , wherein the method is a method for the treatment of opioid addiction in a subject. 
     
     
         63 . The method according to  claim 23 , wherein the method is a method for the treatment of a subject for atopic dermatitis. 
     
     
         64 . The method according to  claim 23 , wherein the method is a method for the treatment or prevention of pruritus in a subject. 
     
     
         65 . (canceled)